Drain vs No Drain After Live Donor Hepatectomy

Drain Versus No-Drain After Live Donor Hepatectomy- A Randomized Controlled, Pilot Study

Prophylactic abdominal drain placement after donor hepatectomy has been a common or even mandatory practice in most transplant centers. This serves to monitor the occurrence of post-operative intra-abdominal bleeding and is used for the detection and drainage of any bile leakage. However prophylactic drain placement is not without complications, like; Increased rates of intraabdominal and wound infection, Increased abdominal pain, Decreased pulmonary function, Bowel injury and Prolonged hospital stay. Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT(Live Donor Liver Transplant) by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.

Study Overview

• Status: Recruiting
• Conditions: Donor Hepatectomy
• Intervention / Treatment: Other: No Drain i.e. Omission of abdominal drain placement

Detailed Description

• This study will be a randomised controlled, pilot study to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.
• Patient admitted for donor hepatectomy will be recruited and further randomised into the Drain and No-Drain arms. Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. For patients in the drain arm, same steps will be followed. At the end of the operation , additionally, 28 Fr abdominal drain will be inserted with tip near cut surface of remnant. Intraoperative and post-operative parameters will be compared between the groups. Comprehensive Complication index will be calculated on day of discharge using online universal CCI calculator application.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bharat Nair, MCh; Phone Number: 08373926785; Email: bharatarcher1@gmail.com
• Study Contact Backup: Name: Priyanka Tripathi; Phone Number: 9873440277; Email: Priyanka.Tripathi@marengoasia.com

Study Locations

• India
  • Haryana
    • Faridabad, Haryana, India, 121002
      • Recruiting
      • Marengo Asia Hospitals
      • Contact: Bharat Nair, MBBS, MS, MRCS, MCh; Phone Number: +91 8373926785; Email: bharatarcher1@gmail.com
      • Contact: Priyanka Tripathi; Phone Number: +91 9873440277; Email: priyanka.tripathi@marengoasia.com
      • Principal Investigator: Bharat Nair, MBBS, MS, MRCS, MCh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Patients undergoing donor hepatectomy -

Exclusion Criteria:

Any patient not consenting to the procedure. Intraoperative need for drain placement in no drain arm due to surgical factors.

Inverted L/ J shaped incision. Laparoscopic donor hepatectomy Robotic donor hepatectomy.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Drain; Patients in the drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which at the end of the operation ,a 28 Fr abdominal drain will be inserted with tip near cut surface of remnant
Experimental: No Drain; Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. No intraabdominal drain will be placed.	Other: No Drain i.e. Omission of abdominal drain placement; Omission of abdominal drain placement in intervention arm. The No-drain arm will be compared to drain arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCI index on post operative day 7	Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms on post operative day 7 after donor hepatectomy.	Admission one day prior to live donor hepatectomy till post operative day 7.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infective complications	Surgical site infections, intra abdominal abscesses	Admission one day prior to live donor hepatectomy till post operative day 7
Duration of hospital stay	Total days of hospitalization required from admission till post operative day 7	Admission one day prior to live donor hepatectomy till post operative day 7
Paralytic ileus	Days to start normal oral diet after surgery	Admission one day prior to live donor hepatectomy till post operative day 7.
Bile leak	Occurrence and detection of bile leak after donor hepatectomy	Admission one day prior to live donor hepatectomy till post operative day 7
Hemorrhage	Occurrence and detection of bleeding after live donor hepatectomy	Admission one day prior to live donor hepatectomy till post operative day 7
Post operative pain scores	Post operative pain as measured by twice daily (Visual Analogue Scale)VAS scores	Admission one day prior to live donor hepatectomy till post operative day 7

Collaborators and Investigators

• Sponsor: Marengo Asia Hospitals
• Investigators: Study Director: Punit Singla, MS,DNB, Marengo Asia Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MAHF/AP/LTP-1/EC/2024/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Name or address in the study data will be coded with initials and number . The confidentiality will be maintained. Unless required by law, only the Study Doctor, the Study Team and its authorized agents and the Ethics Committee/Institution Review Board will have access to confidential data which identifies patients by name or has access to the in patient records of the patient

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No